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The article discusses the durability of high-frequency 10-khz spinal cord stimulation for patients with painful diabetic neuropathy refractory to conventional treatments with 12-month results from a randomized controlled trial. Topics include diabetes will develop painful diabetic neuropathy (PDN) with paresthesia, burning, and shooting pain; and Therapeutic goals include symptom management along with behavioral modifications to mitigate damage.

Introduction: Drawbacks of fixed-output spinal cord stimulation (SCS) screening trials may lead to compromised trial outcomes and poor predictability of long-term success. Evoked compound action potential (ECAP) dose-controlled closed-loop (CL) SCS allows objective confirmation of therapeutic neural activation and pulse-to-pulse stimulation adjustment. We report on the immediate patient-reported and neurophysiologic treatment response post-physiologic CL-SCS and feasibility of early SCS trial responder prediction. Methods: Patient-reported pain relief, functional improvement, and willingness to proceed to permanent implant were compared between the day of the trial procedure (Day 0) and end of trial (EOT) for 132 participants in the ECAP Study undergoing a trial stimulation period. ECAP-based neurophysiologic measurements from Day 0 and EOT were compared between responder groups. Results: A high positive predictive value (PPV) was achieved with 98.4% (60/61) of patients successful on the Day 0 evaluation also responding at EOT. The false-positive rate (FPR) was 5.6% (1/18). ECAP-based neurophysiologic measures were not different between patients who passed all Day 0 success criteria ("Day 0 successes") and those who did not ("needed longer to evaluate the therapy"). However, at EOT, responders had higher therapeutic usage and dose levels compared to non-responders. Conclusions: The high PPV and low FPR of the Day 0 evaluation provide confidence in predicting trial outcomes as early as the day of the procedure. Day 0 trials may be beneficial for reducing patient burden and complication rates associated with extended trials. ECAP dose-controlled CL-SCS therapy may provide objective data and rapid-onset pain relief to improve prognostic ability of SCS trials in predicting outcomes. Trial Registration: The ECAP Study is registered with ClinicalTrials.gov (NCT04319887). [ABSTRACT FROM AUTHOR]

Up to 25% of people with diabetes develop painful diabetic neuropathy (PDN). The standard of care pharmacotherapies for PDN have limited efficacy with a considerable side effect profile. Spinal cord stimulation (SCS) is a form of electrical neurostimulation that modulates neural function via electrodes implanted into the spinal epidural space. While low frequency SCS has been shown to be potentially effective for treating pain associated with neuropathies, it masks pain perception by inducing paresthesia. Compared to low frequency SCS, high frequency (10 kHz) SCS delivers paresthesia-free therapy. As was shown in a randomized controlled trial, SENZA-PDN (NCT03228420), 10 kHz SCS is safe and effective for the treatment of painful diabetic neuropathy. 10 kHz SCS offered a comprehensive treatment that improved pain levels, sleep, quality of life, and neurological function. These improvements correlated with a high degree of patient satisfaction. 10 kHz SCS provides a safe, durable and effective treatment for PDN with the unique potential to improve neurological function. In patients for whom durable, effective treatments have been limited thus far, the findings of the SENZA-PDN study are encouraging. [ABSTRACT FROM AUTHOR]

To evaluate the long-term efficacy of high-frequency (10 kHz) spinal cord stimulation (SCS) for treating refractory painful diabetic neuropathy (PDN). The SENZA-PDN study was a prospective, multicenter, randomized controlled trial that compared conventional medical management (CMM) alone with 10 kHz SCS plus CMM (10 kHz SCS+CMM) in 216 patients with refractory PDN. After 6 months, participants with insufficient pain relief could cross over to the other treatment. In total, 142 patients with a 10 kHz SCS system were followed for 24 months, including 84 initial 10 kHz SCS+CMM recipients and 58 crossovers from CMM alone. Assessments included pain intensity, health-related quality of life (HRQoL), sleep, and neurological function. Investigators assessed neurological function via sensory, reflex, and motor tests. They identified a clinically meaningful improvement relative to the baseline assessment if there was a significant persistent improvement in neurological function that impacted the participant's well-being and was attributable to a neurological finding. At 24 months, 10 kHz SCS reduced pain by a mean of 79.9% compared to baseline, with 90.1% of participants experiencing ≥50% pain relief. Participants had significantly improved HRQoL and sleep, and 65.7% demonstrated clinically meaningful neurological improvement. Five (3.2%) SCS systems were explanted due to infection. Over 24 months, 10 kHz SCS provided durable pain relief and significant improvements in HRQoL and sleep. Furthermore, the majority of participants demonstrated neurological improvement. These long-term data support 10 kHz SCS as a safe and highly effective therapy for PDN. Trial Registration: ClincalTrials.gov Identifier, NCT03228420. [ABSTRACT FROM AUTHOR]

Background: Seven million US adults are living with painful diabetic neuropathy (PDN) with current treatments ineffective for many. Recent RCT results demonstrate high-frequency (10 kHz) spinal cord stimulation (SCS) relieves pain and may improve sensation in patients with refractory symptoms. Methods: Prospective, multicenter RCT assigned 216 patients 1:1 to 10 kHz SCS (Nevro Corp.) plus conventional medical management (CMM) or CMM alone (NCT03228420). Patients had PDN symptoms ≥12 months, lower limb pain ≥5 cm (10 cm visual analog scale), and hemoglobin A1c ≤10%. Outcomes included pain, neurological function, and quality of life over 12 months. Patients could opt to crossover to the alternative treatment at 6 months. Results: Baseline characteristics were similar between groups. At 6 months, 82% of the CMM group crossed over to SCS treatment and none in the 10 kHz SCS group crossed over to CMM. In total, 154 patients underwent SCS implant; 5 (3.2%) were explanted for infection. At 12-month follow-up, there were clear, sustained benefits of 10 kHz SCS in lower limb pain, pain interference with daily living, sleep quality, and activity (Figure). Most patients treated with 10 kHz SCS also showed improvements on neurological examination. Conclusion: The largest RCT to date of SCS management of PDN demonstrates durable pain relief and improved quality of life over 12 months with high-frequency (10 kHz) SCS. Disclosure: E. Petersen: Consultant; Self; Abbott, Medtronic, Nevro Corp., Research Support; Self; Neuros Medical, Inc., Nevro Corp., ReNeuron Group plc, Saluda, Stock/Shareholder; Self; SynerFuse. N. Mehta: Research Support; Self; Nevro Corp. P. W. Wu: None. C. Argoff: Consultant; Self; Nevro Corp., Vertex Pharmaceuticals Incorporated, Other Relationship; Self; Amgen Inc., Eli Lilly and Company, Teva Pharmaceutical Industries Ltd., Speaker's Bureau; Self; AbbVie Inc. C. E. Nasr: Advisory Panel; Self; Nevro Corp. R. Taylor: Consultant; Self; Nevro Corp. Senza-pdn study group: n/a. J. Scowcroft: Research Support; Self; Boston Scientific Corporation, Nevro Corp. E. S. Brooks: Employee; Self; Nevro Corp. J. L. White: Advisory Panel; Self; Eli Lilly and Company, Nevro Corp. K. Amirdelfan: Advisory Panel; Self; Biotronik, Nevro Corp., Consultant; Self; Boston Scientific Corporation. M. Guirguis: Consultant; Self; Avanos medical, Nevro Corp. J. Xu: None. D. G. Patterson: Advisory Panel; Self; Advanced Infusion Systems (AIS), Spark Biomedical, Consultant; Self; Vivex Biologics, Other Relationship; Self; Abbott Laboratories, CornerLoc, Saluda, Vertos Medical Inc., Speaker's Bureau; Self; AbbVie Inc., Amgen Inc., Lundbeck. V. Galan: None. Funding: Nevro Corp. [ABSTRACT FROM AUTHOR]

Background: Six million adults in the U.S. are living with painful diabetic neuropathy (PDN) and current treatments are ineffective for many. Preliminary data suggest 10 kHz spinal cord stimulation (SCS) relieves pain and may improve sensation in refractory patients. Methods: Prospective, multicenter, randomized controlled trial (SENZA-PDN) with 216 subjects assigned 1:1 to 10 kHz SCS (Nevro Corp.) combined with conventional medical management (CMM) or CMM alone. Patients with PDN symptoms ≥12 months, lower limb pain intensity ≥5cm (0-10cm visual analog scale [VAS]), hemoglobin A1c ≤10%, and upper limb pain intensity <3cm were included. Outcomes include pain, neurological function, and quality of life. Results: Randomization of 113 subjects to 10 kHz SCS+CMM and 103 to CMM resulted in groups well-matched at baseline. There were 2 procedure-related infections in the 10 kHz SCS+CMM group (1.8%). At 3-month follow-up, there were clear differences in lower limb pain scores (Fig 1A) and Diabetes Quality of Life (Fig 1B). Patients in the 10 kHz SCS+CMM group demonstrated improvements in sensation on physical examination (Fig 1C) and by patient report of numbness (Fig 1D). In addition, differences between treatment groups were observed in 6-minute walk test distance (Fig 1E) and sleep (Fig 1F). Conclusion: SENZA-PDN is the largest RCT to-date of SCS management of PDN and will inform the treatment continuum. Disclosure: E. Petersen: Consultant; Self; Abbott, Medtronic, Neuros Medical, Nevro. Research Support; Self; Medtronic, Neuros Medical, Nevro, ReNeuron. T. Stauss: None. J.L. White: Research Support; Self; Allergan plc., Astellas Pharma Inc., Bayer Healthcare Pharmaceuticals Inc., Bristol-Myers Squibb, Eli Lilly and Company, Fitbit, Inc., Nevro, NovMetaPharma Co. Ltd., Theracos, Inc. S.M. Sills: None. K. Amirdelfan: Consultant; Self; Biotronik, Medtronic, Nevro Corporation, Saluda. M. Guirguis: Consultant; Self; Boston Scientific, nevro incop, spr. J. Xu: None. C. Yu: None. A. Nairizi: None. D.G. Patterson: Research Support; Self; Nevro Corporation. V. Galan: None. N. Mehta: Advisory Panel; Self; Nevro. Research Support; Self; Nevro. S.P. Lad: None. D. DiBenedetto: None. P.W. Wu: None. C.E. Nasr: Other Relationship; Self; Exilxis, Neurogastrx, Nevro Corp. R. Taylor: Consultant; Self; Nevro. E.S. Brooks: Employee; Self; Nevro. J. Subbaroyan: Employee; Self; Nevro Corp. B. Gliner: Employee; Self; Nevro Corp. D.L. Caraway: Employee; Self; Nevro. N. Mekhail: Consultant; Self; Boston Scientific, Nevro, Nuvectra, Relievant, Saluda, Sollis Therapeutics, Vertos Medical. Research Support; Self; Halyard, Mallinckrodt Pharmaceuticals, Mesoblast, Neuros Medical. Funding: Nevro Corp. [ABSTRACT FROM AUTHOR]

Keywords: deep brain stimulation; glioblastoma multiforme; essential tremor EN deep brain stimulation glioblastoma multiforme essential tremor 526 528 3 03/23/23 20230301 NES 230301 We read with interest the work by Balachandar et al.[1] regarding the presentation of a high-grade glioma in the setting of deep brain stimulator (DBS) placement. Glioblastoma, IDH-Wildtype, CNS WHO Grade 4, Associated with Deep Brain Stimulation in a Patient with Essential Tremor: Report of a Case with Molecular Characterization, and Review of the Literature Here we report a case of the development of a glioblastoma (GBM) 5 years after DBS implantation for essential tremor (ET) including pathology and molecular characterization of the tumor. [Extracted from the article]

Objective For many medical professionals dealing with patients with persistent pain following spine surgery, the term Failed back surgery syndrome (FBSS) as a diagnostic label is inadequate, misleading, and potentially troublesome. It misrepresents causation. Alternative terms have been suggested, but none has replaced FBSS. The International Association for the Study of Pain (IASP) published a revised classification of chronic pain, as part of the new International Classification of Diseases (ICD-11), which has been accepted by the World Health Organization (WHO). This includes the term Chronic pain after spinal surgery (CPSS), which is suggested as a replacement for FBSS. Methods This article provides arguments and rationale for a replacement definition. In order to propose a broadly applicable yet more precise and clinically informative term, an international group of experts was established. Results 14 candidate replacement terms were considered and ranked. The application of agreed criteria reduced this to a shortlist of four. A preferred option—Persistent spinal pain syndrome—was selected by a structured workshop and Delphi process. We provide rationale for using Persistent spinal pain syndrome and a schema for its incorporation into ICD-11. We propose the adoption of this term would strengthen the new ICD-11 classification. Conclusions This project is important to those in the fields of pain management, spine surgery, and neuromodulation, as well as patients labeled with FBSS. Through a shift in perspective, it could facilitate the application of the new ICD-11 classification and allow clearer discussion among medical professionals, industry, funding organizations, academia, and the legal profession. [ABSTRACT FROM AUTHOR]

The article describes the case of a 59-year-old patient with granulomatous amebic encephalitis (GAE). The symptoms manifested by the patient include headache and diffuse numbness and tingling. The results of physical examination, laboratory tests and imaging done on the patient are mentioned. Background information is provided on the condition as well as the outcome of treatment.

Well-designed instructional programs seamlessly promote human performance. Students are often unaware of countless iterations of formative evaluation completed to improve effectiveness, efficiency, motivation, and flow of that instructional design. This paper examines one research-based, comprehensive, systematic evaluation approach as applied by students through two case studies where they evaluated instructional design at a macro level of real-world training programs. The 10-Step Evaluation for Training and Performance Improvement (Chyung 2019) was piloted in a graduate-level instructional design and technology class. Lessons learned include evaluators recognizing the importance of honing in on the questions to ask to determine the dimensions to evaluate while remaining unbiased with their assumptions. For example, results from the first case initially focused on a summative evaluation that hypothesized that the program should be discontinued. Conversely, that case actually uncovered unanticipated findings that resulted in recommendations for the program to be revamped in an effort to continue improvement of human performance. [ABSTRACT FROM AUTHOR]

• During the COVID-19 pandemic, many conferences were converted to virtual formats. • Online offerings should allow for conference panels to include more female speakers. • We conducted a cross-sectional observation of webinars at the beginning of the COVID-19 pandemic. • Webinars organized by industry (vs professional societies) included fewer women (10% vs 28%). • Webinar organizers must be intentional with the gender distribution of panel speakers. [ABSTRACT FROM AUTHOR]